Contact the VA Human Research Protection (HRPP) Office if you are considering conducting research at the VAMC. The telephone number is (352) 548-6000 extension(s) 10-4925 or 10-4901.

IRB-01 is the the Institutional Review Board (IRB) of record for the North Florida/South Georgia Veteran’s Health System (NF/SG VHS). Although the NF/SG VHS is considered an affiliated campus of the University of Florida, it is a separate federal institution that has its own additional requirements for conducting research. In order to conduct research at the NF/SG VHS researchers must obtain prior approval from both IRB-01 and the appropriate offices in the NF/SG VHS.

In particular, researchers are required to obtain approval from the VA Research & Development (R&D) Committee and its appropriate subcommittees reviews for all research studies that(1) utilize VA resources or facilities, (2) involve VA patients (including their medical information or PHI), (3) involve VA staff, including part-time staff, without compensation employees (WOC), and/or fee-basis, contract and consultants.

No research project may commence at the NF/SG VHS prior to final approval by the R&D Committee. These procedures apply to all research projects regardless of funding source.

If you are affiliated with the NF/SG VHS: You must submit your materials to both the VA Human Research Protection (HRPP) Office and IRB-01. You must obtain approval from both the IRB and VA R&D before you may initiate your research.

If you are not affiliated with the NF/SG VHS: You will need to identify a full or part-time VA compensated Investigator who will accept responsibility for the conduct of the work at the VA. Please submit all materials to the VA Office of Research and Development at the same time you submit to IRB to avoid unnecessary delays. Both offices work closely together, but it It is the PI’s responsibility to ensure the VA receives all materials in a timely manner.

Conducting clinical research at the NF/SG VHS has additional considerations separate from UF:

The NF/SG VHS grants PI status independently from UF—Permission to conduct research at UF does not automatically grant permission to perform research at the VAMC. In order to conduct any research at the VA, you must: (1) at least one full- or part-time VA compensated staff member serving as an investigator on each protocol, or (2) receive separate express written permission from the VA R&D to conduct your project at the VA. (3) The VA also requires researchers to complete additional, annual training on human subjects protections (see below).

There is a separate approval process at the NF/SG VHS; If the study will be conducted all or in part at the VA, even if you have IRB approval, the study must also be reviewed by the VA Human Research Protection (HRPP) Office and approved by the VA’s R&D Committee. These committees oversee all human subjects research activity under the auspices of the NF/SG VHS, including adverse events, revisions and continuing review. The R&D Committee may disapprove an IRB approved research activity or may have additional requirements, conditions, or modifications. (NOTE: if the VA committees require any changes you may not implement any changes until you also obtain IRB approval for them).

There are training, credentialing and documentation requirements for all persons working with human subjects, human tissue or human subject data at the NF/SG VHS.

Some research appropriate at UF is not appropriate for the NF/SG VHS, or may need significant additional approvals (e.g., research involving minors and prisoners) or documentation (incompetent persons) prior to VA approval.

The consent document for use at the NF/SG VHS requires a specific form (VA Form 10-1086) and additional language that is required by VHA. If both affiliate and VA subjects are going to be enrolled, you will need to submit two versions, UF and VA, for type of consent you intend to use. The HIPAA authorization for the VA consent is a separate document “Authorization for Use and Release of Individually Identifiable Health Information for Veterans Health Administration (VHA) Research” VA Form 10-0493.

Approved study revisions, please remember that all revisions must be submitted to the IRB first for review and approval, except for making changes to VA HIPAA authorization. Once the IRB has approved any revision to the study, you must contact the HRPP office staff to inform them of the approved change(s) to ensure the VA study file is current and in compliance. The IRB does not review or approve the VA HIPAA authorization, therefore any revisions to the VA HIPAA authorization (VA Form 10-0493) form need to be submitted to the HRPP office for review and approval.

The NF/SG VHS may have additional charges depending on the services and facility support needed to conduct the research .